Device and method for assisting end-to side anastomosis

ABSTRACT

The present invention provides a device and method for creating a seal around the inner wall of an incision in a blood vessel. The device is particularly adapted to create an anastomosis site for coronary artery bypass grafts to a patient&#39;s aorta without obstructing the flow of blood in the aorta. The device comprises an extruded tube with a translatable shaft positioned therein. One end of the shaft is coupled to a handle of the device which allows a practitioner to advance and withdraw the shaft relative to the tube or, in an alternative embodiment, to advance and withdraw the tube relative to the shaft. The other end of the shaft is connected to a flexible inverting member which is attached to the distal end of the tube. By manipulating the handle, the practitioner can remotely deform the inverting member between two configurations: an elongated, narrow configuration in which the inverting member is adapted to be inserted through a small incision, and an inverted configuration in which the inverting member forms an expanded, inward-facing cup. In operation, the medical practitioner inserts the inverting member into the blood vessel through an incision while the inverting member is maintained in its elongated, narrow configuration, and then manipulates the handle to cause the inverting member to assume its inverted configuration. A seal is then formed by applying a proximal force to the device to cause a rim of the cup to form a seal against an inner wall of the blood vessel. This prevents blood from flowing out of the incision and creates a working area for performing an end-to-side anastomosis. The working area is formed without interrupting the flow of blood through the vessel. The device preferably includes a hole punch device slidably mounted to the tube for allowing the practitioner to create an anastomosis hole once the seal has been formed.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Pat. Ser. No.5/944,730 filed Mar. 6, 1998, which in turn claims the benefit of U.S.Provisional Application No. 60/046,972 filed May 19, 1997.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices and methodsof use thereof. Specifically, the present invention relates to medicaldevices used to create a seal around an incision for performing anend-to-side anastomosis procedure on the aorta or other blood vessel.

2. Description of the Related Art

Currently, the standard practice in performing a coronary artery bypasssurgical procedure is to open the patient's chest, place the patient ona cardiopulmonary bypass (heart-lung) machine, stop the heart frombeating, and then attach the coronary artery bypass graft(s) to theaorta and coronary arteries. The heart-lung machine is needed tomaintain the blood circulation through the patient and to provide gasand heat exchange surfaces. Typically, the blood is cooled using theheart-lung machine to slow down the metabolism of the patient.Additionally, the blood is oxygenated and carbon dioxide is allowed tobe released from the blood. The aorta is usually clamped proximal to theentrance point of the blood from the heart-lung machine.

There can be numerous complications with stopping the patient's heartand using a heart-lung machine. The heart-lung machine typically needsto be primed with blood. This is usually done with blood from a bloodbank which can be contaminated with infectious agents such as the HIVvirus. The heart-lung machine can lyse red blood cells and destroyplatelets causing anemia or increasing the risk of hemorrhage. Theclamping of the aorta can release plaque into the blood stream, whichcan cause a stroke or a peripheral vascular incident.

Another technique is to partially cross-clamp the aorta with a “U”shaped clamp such that a small blood tunnel is created and an area ofblood stasis is created for making a proximal anastomosis site. Thistechnique eliminates the heart-lung machine, but increases the risk ofplaque releasing into the blood stream.

Thus, it is desirable to have a device and method that greatly reducesthe risks associated with coronary artery bypass surgical procedures.

SUMMARY OF THE INVENTION

The present invention relates to a device and method for creating ananastomosis site along a wall of a blood vessel without interrupting theflow of blood through the blood vessel. The device may be used invarious applications which involve incisions made in the aorta, otherblood vessels or organs. The device is particularly suited to create ananastomosis site for coronary artery bypass grafts without obstructingthe flow of blood in the patient's aorta. Thus, the device may be usedwhile the patient's heart is beating without the use of a heart-lungmachine or a cross clamp.

In a preferred embodiment, the device comprises an extruded hollow tubewith a wire or shaft which slides within the tube. A flexible invertingmember is attached to the distal end of the tube and coupled to a distalend of the shaft. A proximal portion of the shaft is coupled to anactuation assembly of the device, which preferably comprises a handle.By manipulating the handle, the practitioner can remotely deform theinverting member between two different configurations: an elongated,narrow configuration in which the inverting member may be advancedthrough a small incision, and an expanded, inverted configuration inwhich the inverting member forms a cup that can be used to form a sealedpocket against the inner wall of a blood vessel.

In operation, the medical practitioner inserts the inverting member intothe blood vessel through an incision while the inverting member is inits elongated, narrow configuration. The medical practitioner thenmanipulates the translatable shaft inside the hollow tube, oralternatively, the hollow tube itself, (preferably by manipulating ahandle of the device) to expand the inverting member into its invertedconfiguration. The practitioner then applies a proximal force to thedevice to cause a seal to be formed by the radial rim of the invertingmember pressing against the inner wall of the blood vessel. Thisprevents blood from flowing out of the incision, without obstructing theflow of blood in the blood vessel, and creates a working area forperforming an end-to-side anastomosis.

In one embodiment, the device includes a hole puncher which is slidablymounted on the hollow tube. Once the seal has been formed inside theblood vessel, the hole puncher is slidably advanced distally to theouter surface of the blood vessel, and is then actuated to form ananastomosis hole around the entry point of the tube. The hole canalternatively be formed manually using a scalpel or other cuttingdevice. In either case, the hole falls within the boundaries of theinverting member's rim, and is thus isolated from the flowing blood inthe blood vessel.

Once the anastomosis hole has been formed, a bypass graft is looselysutured around the outside of the hole while the seal is maintainedbetween the inverting member's rim and the blood vessel's inner wall.The inverting member is then returned to the elongated, narrowconfiguration and withdrawn from the hole, and the ends of the sutureare pulled tight to cause the end of the graft to contact the bloodvessel.

These and other features and advantages of the present invention aremore fully set forth in the following Detailed Description and theaccompanying figures in which similar reference characters denotesimilar elements throughout the several views.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of one embodiment of the present invention.

FIG. 2 is a cross-sectional view of the embodiment of FIG. 1.

FIG. 3 is a top view of the retaining disk in the embodiment of FIG. 1.

FIG. 4 is a cross-sectional view of the retaining disk of FIG. 3.

FIG. 5 is a cross-sectional view of the distal inverting member in theembodiment of FIG. 1.

FIG. 6 is a cross-sectional view of an proximal inverting member in theembodiment of FIG. 1.

FIG. 7 is a side view, partially in cross-section, of a piston in theembodiment of FIG. 1.

FIG. 8 is a distal end view of the piston of FIG. 7.

FIG. 9 is a proximal end view of the piston of FIG. 7.

FIG. 10 is a side view, partially in cross-section of the handle in theembodiment of FIG. 1.

FIG. 11 is a distal end view of the handle of FIG. 10.

FIG. 12 is a proximal end view of the handle of FIG. 10.

FIG. 13 is a schematic cross-sectional view of the inverting member inthe embodiment of FIG. 1 in its resting configuration.

FIG. 14 is a schematic cross-sectional view of the inverting member ofFIG. 13 in its stretched, elongated and narrow configuration.

FIG. 15 is a schematic view of the inverting member of FIG. 13 in itsinverted, cup-shaped configuration.

FIG. 16 is a schematic view of the inverting member of FIG. 13 in itsinverted, cup-shaped configuration inserted in a blood vessel topartially occlude the vessel and completely occlude a surgically createdincision in the vessel.

FIGS. 17 and 17A are side views of another design of the invertingmember extended in an elongated, narrow configuration.

FIG. 18 is a side view of the inverting member of FIG. 17 in a neutralconfiguration.

FIG. 19 is a side view of the inverting member of FIG. 17 in an invertedconfiguration.

FIG. 20 is a cross-sectional view of the inverting member of FIG. 19.

FIG. 21 is a side view of another embodiment of the present invention.

FIG. 22A is a cross-sectional view of the inverter control handle in theembodiment of FIG. 21.

FIG. 22B is a cross-sectional view of the translatable, hollow piston ofFIG. 21 in its most proximal position.

FIG. 22C is a cross-sectional view of the translatable, hollow pistonand releasor of FIG. 21.

FIG. 23 is a cross-sectional view of the hole puncher of FIG. 21.

FIGS. 24A and 24B illustrate one method of preforming the invertingmember in the embodiment of FIG. 21.

FIG. 25A illustrates how an incision is made in the side of a bloodvessel.

FIG. 25B illustrates the inverting member inserted into the incision ofFIG. 25A.

FIG. 25C illustrates the inverting member of FIG. 25B expanding in theblood vessel to create a seal.

FIG. 25D illustrates the insertion of the hole puncher of FIG. 21.

FIG. 25E illustrates the operation of the hole puncher of FIG. 25D.

FIG. 26A illustrates how a bypass graft may be attached to the bloodvessel with the inverting member inside the blood vessel.

FIG. 26B illustrates the bypass graft of FIG. 26 with a small slit tofacilitate removal of the inverting member.

FIG. 27 illustrates the bypass graft of FIG. 26 being attached to theblood vessel with a purse string suture.

FIG. 28 illustrates how a practitioner pulls the ends of the pursestring suture of FIG. 27 to bring the bypass graft to the blood vessel.

FIG. 29 illustrates a distal portion of a device according to a thirdembodiment of the present invention.

FIG. 30 illustrates how a deformable inverting member of the FIG. 29device expands outward.

FIG. 31 is a cross-sectional view which illustrates the inverting memberof the FIG. 29 device in its cup-shaped configuration.

FIGS. 32A-32B are cross-sectional views of another embodiment of theinverter control handle.

FIG. 33 is a perspective view of an alternative handle embodiment.

FIGS. 34A, 34B, and 34C are cross sectional views of a device having thehandle of FIG. 33, showing the operation of the device as the handle ismoved between the pre-cocked, cocked, and pre-triggered configurations,respectively.

FIGS. 34D and 34E are cross sectional views showing how the invertingmember inverts relative to a vessel wall as the FIG. 33 handle is movedfrom the triggered configuration to the deployed configuration,respectively.

FIGS. 35A and 35B show perspective cutaway views of the handle of FIG.33.

FIG. 35C shows a cross sectional view of various components of thehandle corresponding to the configuration shown in FIG. 34B.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Several embodiments of the invention and variations of these embodimentswill now be described with reference to the drawings. Other embodimentswill be apparent to those skilled in the art. Although the invention isdescribed in terms of several separate embodiments, it will berecognized that many of the features and components of these differentdesigns can be appropriately combined and/or interchanged.

The various embodiments of the device described herein make use of aflexible, deformable member which inverts “inward” to form a cup havingan opening which faces the shaft to which the flexible member isattached. The shaft is then advanced proximally (toward the physician)to draw the rim of the cup against the wall of the artery, around theentry point of the shaft. In other embodiments, a deformable member maybe used which inverts or deforms “outward,” so that the opening of thecup faces away from the shaft to form a plunger-like configuration. Theshaft would then be pushed distally (away from the physician) to form aseal against the far wall of the artery.

First Embodiment

FIGS. 1-20 illustrate a first embodiment of the present invention. Asillustrated by FIGS. 1 and 2, this embodiment comprises a proximal outerhandle 16 with a translatable piston 17 slidably retained within thehandle 16. Attached to the distal center of the handle 16 is a hollowextrusion 12. The extrusion 12 extends distally to the proximalinverting member 15 which is bonded to the extrusion 12 and bonded tothe distal inverting member 14. The proximal and distal invertingmembers 15, 14 are preferably made out of a flexible compliantbiocompatible material such as polyurethane, Dynaflex, silicone, and thelike. The two inverting members, 14, 15 may alternatively be formed as asingle member as described below.

A translatable wire 11, or other type of shaft, is attached to thecenter of the piston 17 and attached to the internal distal tip of thedistal inverting member 14 via a retaining disk 13. The translatablewire 11 traverses through a lumen of the extrusion 12. The wire 11 andretaining disk 13 are preferably made out of a durable material such asstainless steel.

In an alternative design, the translatable wire 11 may be a thin, hollowtube, called a “hypotube,” which has open ends and the distal andproximal ends of the device. This tube can be used either for bleed backor to insert a guidewire into the blood vessel.

FIG. 2 shows a spring 18 retained within the handle 16 such that itexerts force on the piston 17 to urge the piston 17 away from (andproximal to) the handle 16. This causes the wire 11 to be translatedproximally relative to the extrusion 12 and, as explained further below,causes the inverting members 14, 15 to be in an inverted state at rest.

FIGS. 3 and 4 illustrate the retaining disk 13. The retaining disk 13 ispreferably cylindrical in shape with tapered sides. Provided in thecenter of the retaining disk 13 is a central hole 32. The translatablewire 11 is welded inside the central hole 32. Also provided in theretaining disk 13 are a plurality of radial holes 31 running parallel tothe center hole 32. The radial holes 31 are used during the molding ofthe distal inverting member 14 such that the material of the distalinverting member 14 can travel through the holes 31 and a better bondcan be created (see discussion below).

FIGS. 5 and 6 illustrate the distal and proximal inverting members 14,15 respectively. The inverting members 14, 15 are preferably made out ofa molded compliant biocompatible material such as polyurethane, or inthe alternative, it can be made out of a braided mesh that is totally orpartially covered by a compliant material. The distal inverting member14 is preferably cup-shaped. The distal inverting member 14 is moldedwith the retaining disk 13 and wire 11 in place, allowing the materialto be formed within the radial holes 31 of the retaining disk 13. Thedistal member is thickest at the distal tip 35 and has an additionalinner cone 36 that is formed around the proximal surface of theretaining disk 13. The proximal end of the distal inverting member 14has a notch 37 for mating with the proximal inverting member 15.

The proximal inverting member 15 is also cup shaped. The sides of thecup are somewhat serpentine shaped and have two concave portions 43 and44 respectively when viewed from the outside. The distal end of theproximal inverting member 15 has a notch 45 for mating with the notch 37of the distal inverting member 14. At the proximal apex there isprovided a cylindrical tunnel 41 for bonding to the outer surface of theextrusion 12. A central smaller hole 42 is provided for the translatablewire 11 to travel through.

FIGS. 7-9 illustrate the translatable piston 17. The piston isessentially cylindrical in shape with a proximal flat surface 52 and adistal flat surface 60. Provided within the center of the piston 17 is ashaft 51 for mounting the translatable wire 11. A set screw hole 22 isprovided along the side of the piston 17 for placing a set screw (notshown) to purchase the translatable wire 11. Holes 59 are also providedalong the sides 56 of the piston to allow for the placement of retainingpins. The retaining pins travel in the retaining slots 67 of the handle16 (FIG. 10). A third hole 57 is provided for pinning the piston 17 in aneutral position for storing the device when not in use. The mostproximal end of the piston 17 has a thumb rest 53.

FIGS. 10-12 illustrate the handle 16. The handle 16 is a cylindricalmember that is partially hollowed out to receive the piston 17. Thepiston 17 travels in the bore 69 which ends at floor 70. The spring 18is placed in the bore 69 between the floor 70 and the distal end 60 ofthe piston 17. The extrusion 12 in FIGS. 1 and 2 is inserted into alumen 71 in the distal end 66 of the handle 16 and is set in place by aset screw threaded through hole 72. A pinning hole 21 is provided nearthe proximal end 65 to pin the piston 17 in a neutral position. Slots 67are provided on opposite sides of the handle 16 to limit the travel ofthe piston 17.

FIGS. 13-16 illustrate the distal end of the device of FIG. 1 inoperation. When the device is stored or shipped, the piston 17 is pinnedin a neutral position as illustrated in FIG. 13. In the descriptionbelow, the device is used to create a working area for coronary arterybypass grafts to the aorta. The device may, however, conceivably be usedin a variety of other operations involving incisions in blood vessels ororgans.

In coronary artery bypass grafting, the patient is prepped and access tothe aorta is established by either an open chest procedure, port access,or via a small lateral incision in the ribs. Once the aorta is accessed,a small incision 82 (FIG. 25A) is made in the aorta at a proximalanastomosis site for a coronary artery bypass procedure. The invertingmembers 14, 15 are then extended by translating the wire 11 distallyusing the piston 17 as illustrated in FIG. 14. This changes theconfiguration of the inverting members 14, 15 to an elongated, narrowconfiguration. The inverting members 14, 15 are then placed within theaorta through the small incision 82. The inverting members, 14, 15 arethen “inverted” by quickly translating the wire 11 proximally asillustrated in FIG. 15. This is achieved by releasing all force on thepiston 17 to let the spring 18 in the handle 16 move the wire 11proximally. The inverting members 14, 15 change to an inverted position,forming a cup-shaped space within the inverting members 14, 15.

Next, the operator applies proximally directed tension to the device toseal the edges of the cup to the inner wall 81 of the aorta asillustrated in FIG. 16. The device only occludes the area of the aortaaround the incision 82 and does not otherwise obstruct the flow of bloodin the aorta. Blood flows from the heart, past the distal end of thedistal inverting member 14, and to the peripheral tissues. Thus, thedevice prevents blood from escaping the surgical site but does notrequire the heart to be stopped. Once the seal has been formed toprovide a working area, the medical practitioner widens the incision asneeded to create a proximal anastomosis site for a coronary bypassgraft. The practitioner then loosely sutures one end of a coronaryartery bypass graft (typically a section of a saphenous vein) to thehole. The practitioner allows enough slack on the suture to be able toremove the device. The procedure for attaching the graft is describedfurther below in connection with a second embodiment of the invention.

After the suture or sutures are in place, the practitioner translatesthe wire 11 distally to cause the inverting members 14, 15 to reform theelongated and narrow configuration as illustrated in FIG. 14. Thepractitioner then removes the inverting member from the aorta around theloose sutures and pulls the sutures around the graft tight to give thegraft a good seal. The other end of the coronary artery bypass graft isattached to a surgically created hole in a coronary artery while theheart is still beating before, during, or after the aortic anastomosis.The rest of the coronary bypass procedure is completed using standardtechniques.

FIGS. 17-20 illustrate various designs of an alternative invertingmember 151. The inverting member 151 is preferably a single piece and iscreated out of a flexible, braided tube or sleeve 115, such asone-quarter inch expandable mesh sleeving of the type used to houseelectrical conduits. The braided tube 115 is preferably in the form of awireloom weave of a material known as PET. The distal end 116 of thebraided tube 115 is preferably attached to the distal end of a wire orrod 111 using either an injection-molded PET tip or a UV-cured adhesivetip. The proximal end 117 of the tube 115 is preferably attached to thedistal end of the extrusion 112 using a thermal bonding process, but mayalteratively be attached using an adhesive.

As illustrated in FIG. 17A, the entire inverting member 151 ispreferably coated with a flexible, impermeable material such as siliconeto make the inverting member impermeable to the flow of blood. As shownin FIGS. 17, 18, and 19, the silicone coating may alternatively beapplied to only the distal half 114 or two-thirds of the mesh sleeving115. Preferred processes for preforming and coating the mesh sleeving115 are described below.

A handle and piston are attached to the proximal end of the extrusion112. The handle and piston can be the same as described above and arenot illustrated.

This inverting member 151 generally operates in the same manner as theinverting members 14, 15 described above. When the operator causes thewire 111 to move distally relative to the extrusion or tube 112, theinverting member 151 assumes an elongated and narrow configuration asillustrated in FIG. 17. When the operator causes the wire 111 to moveproximally relative to the extrusion 112, the inverting member 151expands radially and then inverts, as illustrated in FIGS. 18 and 19.

Second Embodiment

A device according to a second embodiment of the invention will now bedescribed with reference to FIGS. 21-26, 32A and 32B. As illustrated inFIG. 21, the device features a flexible one-piece inverting member witha handle 180 and hole puncher 178. In a preferred embodiment, theinverting member 151 in FIG. 21 has the same general construction (but aslightly modified configuration) as that of the one-piece invertingmember 151 described above and illustrated in FIGS. 17-20. The entireflexible surface of the inverting member is preferably coated withsilicone.

FIGS. 24A-24B illustrate a manufacturing process for preforming the meshsleeve of the inverting member 151 to cause the inverting member toassume the configurations generally shown in FIGS. 17-20 upon theapplication or removal of an appropriate longitudinal biasing force.This process is preferably performed before the inverting member 151 isattached to the other parts of the device.

In FIG. 24A, a rod 232 is inserted through the mesh sleeving 228, whichis preferably of the same construction as described above. As shown inFIG. 24A, both the rod 232 and the mesh sleeving 228 are inserted into acompression mold 230. A compressor 234 at the proximal end is slidablyreceived in the compression mold 230. Both the compressor 234 and thecompression mold 230 are preferably cylindrical and made of stainlesssteel. The compressor 234 pushes the proximal end of the expandablesleeving 228 into the rest of the sleeving 228 (causing the sleeving toinvert) until the compressor 234 reaches its compressor groove 236. Thesleeving 228 is held in this position and pressure is applied to form acrease in the sleeving 228. The sleeving 228 will thereafter naturallydeform into this configuration if pressure is applied to the proximalinverting portion 156. This preforming method may be done solely withpressure and without heat.

A variety of techniques are available for coating the preformedinverting 151 member with silicone. One preferred technique involvesdipping the uncoated inverting member 151 in a silicone solution (oralternatively, spraying the silicone on the mesh), and then varying theshape of the inverting member 151 over a range of configurations duringthe drying process. This process is preferably performed twice toachieve a sufficient thickness. Silicone is then manually applied bybrush to the weaker portions of the coating to provide reinforcement.

In one embodiment, the above dipping/drying process is performed priorto attaching the extrusion or tube 160 (FIG. 23) to the proximal end ofthe inverting member; this allows the xylene gas that is released duringthe drying process to escape through the opening in the proximal end ofthe inverting member. Alternatively, the process may be performed afterattaching the inverting member 151 to the extrusion 160, in which case ahole will normally be blown in the silicone coating during the dryingprocess. The hole can then be patched manually.

FIG. 22A is a cross-sectional view of the inverter control handle 180 ofthe embodiment illustrated in FIG. 21. The inverter control handle 180comprises a translatable, hollow piston 17 and a proximal outer handle16. As in the embodiments described above, the translatable piston 17 ofthe inverter control handle 180 may be cylindrical in shape and slidablyretained inside outer handle bore 69. The operation of the invertercontrol handle 180 in this embodiment is generally the same as in theembodiment described above, except for the differences noted below.

The piston spring 18 within the outer handle bore 69 exerts force on thetranslatable piston 17 in a proximal direction, away from the outerhandle 16. A retaining pin 190 on the piston 17 protrudes radially frompiston 17 and slides in a retaining slot 67 (in FIG. 21) on the outerhandle 16. When the retaining pin 190 is at the proximal end 220 of theretaining slot 67, the stabilizing force of the retaining pin 190counters the force of the piston spring 18 and keeps the piston 17 fromsliding out of the outer handle 16. The control handle 180 has a pair ofretaining pins 190 and slots 67, located on opposite sides of the piston17 and outer handle 16. When the piston 17 is extended to its farthestdistance from the outer handle 16 as in FIG. 22B, the inverting member151 is in its inverted configuration.

A releasor 196 pivots on a releasor pin 208, which is attached to theinterior of the hollow piston 17. A releasor spring 210 exerts force onthe releasor 196 and keeps the releasor lever 218 in its extendedposition, the position farthest from the piston 17. This is shown inFIG. 22A. The lever 218 of the releasor 196 protrudes from the exteriorsurface of the piston 17 through a releasor aperture 200. A releasorlatch 202, located at the distal end of the releasor 196, protrudes fromthe exterior surface of the piston 17 through a latch aperture 219. Thisis shown in FIG. 22B.

By pushing the releasor lever 218 toward the piston 17, the releasorspring 210 compresses, and the releasor 196 pivots on the releasor pin208. This is shown in FIG. 22C. There are preferably three positiongrooves 212, 214, 216 molded into the internal surface of the handlebore 69. These grooves 212, 214, 216 are used to catch and hold thereleasor latch 202. More than three grooves may alternatively beincluded to provide for more than three positions of the invertingmember 151.

The use and operation of the inverter control handle 180 will now bedescribed with reference to FIGS. 21-23. First, the medical practitionerbraces his or her fingers on finger grips 194 on the outer handle 16 andpushes the thumb (or palm) rest 53 distally toward the handle 16 tostretch the inverting member 151 into its elongated, narrowconfiguration. This pushes the piston 17 into the handle bore 69 andcompresses the piston spring 18 within the handle bore 69. Continuedpressure on thumb rest 53 causes the angled surface 206 of the releasorlatch 202 to come in contact with the proximal end 65 of the handle 16.The angled surface 206 allows the releasor latch 202 to slide smoothlyinto the handle bore 69. This causes the releasor spring 210 tocompress.

The releasor latch 202 continues to slide inside the handle bore 69until the releasor latch 202 falls into a first position groove 212.This is shown in FIG. 22A. When the latching surface 204 of the releasorslides into the first position groove 212, the combined forces of thepiston spring 18 and the releasor spring 210 lock the piston 17 into afirst position. In this first position, the inverting member 151 isabout two-thirds extended to its elongated, narrow configuration. Thisconfiguration may or may not be narrow enough to insert or withdraw theinverting member 151 into or out of the incision made in the bloodvessel.

If this retracted configuration is not narrow enough, the medicalpractitioner pushes on thumb rest 53 until the releasor latch 202 slidesinto a second position groove 214. In this second position, according toone embodiment, the inverting member is about four-fifths extended toits elongated, narrow configuration. If this configuration is still notnarrow enough, the medical practitioner pushes on thumb rest 53 untilthe releasor latch 202 slides into a third position groove 216. In thisthird position, the inverting member is roughly nine-tenths or all theway extended to its elongated, narrow configuration. The practitionercan then insert or withdraw the inverting member 151 into or out of anincision made in a blood vessel.

In an alternative design, the distal tip 152 of the inverting member 151may be used to create the initial incision. In this case, the invertingmember 151 slides in through the incision immediately after the incisionis made.

When the releasor latch 202 is in any of the position grooves 212-216,the practitioner can transform the inverting member 151 into itsinverted configuration instantly by pressing the releasor lever 218.Specifically, the practitioner pushes the releasor activation surface198 toward the piston 17. The releasor spring 210 compresses and thereleasor latch 202 lifts out of its current position groove. Thisreleases the piston 17 from its locked position, and the piston spring18 instantly snaps the piston 17 back to its most proximal position. Theretaining pin(s) 190, comes in contact with the proximal end of theretaining slot 67 to prevent the piston 17 from shooting out of thehandle bore 69.

This sudden snapping motion inverts the inverting member 151 to itsinverted configuration instantly so that a minimum amount of bloodescapes through the incision 82 in the blood vessel. The quicker theinverting member 151 inverts, the quicker a seal can be formed againstthe inner walls of the blood vessel. Next, proximally directed tensionis applied to the device to seal the edges of the inverting to member tothe wall of the blood vessel.

FIGS. 32A and 32B illustrate an alternative handle implementation forthe FIG. 21 device. The inverter control handle 252 comprises a hollowouter handle 256, a first piston spring 258, a second piston spring 280,a translatable piston 286, a releasor 270, and a translatable compressor284. The operation of the inverter control handle 252 shown in FIGS.32A-32B is generally the same as in the embodiments described above,except for the differences noted below.

The distal end 254 of the outer handle 256 is attached to the proximalend of the flexible extrusion (tube) 160. The distal portion 260 of thepiston 286 is attached to the proximal end of the translatable wire 111.The first piston spring 258 within the outer handle bore 290 exertsforce on the translatable piston 286 in a proximal direction. The secondpiston spring 280 within the outer handle bore 290 exerts a force on thetranslatable piston 286 in a distal direction, which counters the forceof the first piston spring 258 and keeps the piston 286 from sliding outof the outer handle 256. The second piston spring 280 also exerts aforce on the translatable compressor 284 in a proximal direction. Thedistal end 292 of the compressor 284 is formed so that it prevents thecompressor from sliding completely out of the outer handle bore 290. Thepiston 286 is also formed with a groove 288 to slidably receive thereleasor 270. When the piston 286 is extended to its farthest proximalposition as in FIG. 32B, the inverting member 151 is in its invertedconfiguration.

The releasor 270 pivots on a releasor pin 274, which is attached to theinterior of the hollow handle 256. A flexible releasor support pin 272exerts force on the releasor 270 and keeps the distal end of thereleasor 270 in contact with the piston 286. The support pin 272performs basically the same function as the releasor spring 210 in FIG.22A described above. The lever 278 of the releasor 270 protrudes fromthe exterior surface of the handle 256 through a releasor aperture 276.By pushing the releasor lever 278 toward the handle 256, the releasorsupport pin 272 compresses, and the releasor 270 pivots on the releasorpin 274. This is shown in FIG. 32B. There are preferably four positiongrooves 262, 264, 266, 268 molded into the internal surface of thepiston 286. These grooves 262, 264, 266, 268 are used to catch and holdthe piston 286. More than four grooves may alternatively be included toprovide for more than four positions of the inverting member 151.

The use and operation of the inverter control handle 252 will now bedescribed with further reference to FIGS. 32A-32B. First, the medicalpractitioner begins with the inverter control handle 252 in the positionshown in FIG. 32B. The practitioner braces his or her fingers on fingergrips 282 on the outer handle 256 and pushes the translatable compressor284 distally to stretch the inverting member 151 into its elongated,narrow configuration. This pushes the second piston spring 280 distallywithin the handle bore 290 into the piston 286 and compresses the firstpiston spring 258. Continued pressure on compressor 284 causes thedistal end of the releasor 270 to slide inside the piston groove untilthe distal end of the releasor 270 falls into a first position groove262.

When the distal end of the releasor 270 slides into the first positiongroove 262, the combined forces of the first piston spring 258, thesecond piston spring 280 and the releasor support pin 272 lock thepiston 286 into a first position. In this first position, the invertingmember 151 is partially extended to its elongated, narrow configuration.With the handle 252 in this position, the inverting member 151 may ormay not be narrow enough to inserted or withdrawn through the incision82 (FIG. 25A) made in the blood vessel.

If the inverting member is not stretched to a sufficiently narrowconfiguration at this stage, the medical practitioner can further reducethe cross sectional circumference of the inverting member 151 by pushingthe compressor 284 until the distal end of the releasor 270 slides intoa second, third or fourth position groove 264, 268, 268. Once thedesired configuration has been obtained, the practitioner inserts orwithdraws the inverting member 151 into or out of the incision.

When the distal end of the releasor 270 is in one of the positiongrooves 262-268, the practitioner can transform the inverting member 151into its inverted configuration instantly by pressing the releasor lever278 in the direction of the arrow in FIG. 32A. Pressing the releasorlever 278 causes the releasor support pin 272 to bend inward, and causesthe distal end of the releasor 270 to lift out of the current positiongroove. This releases the piston 286 from its locked position, and thefirst piston spring 258 instantly snaps the piston 286 back to its mostproximal position. The second piston spring 280 prevents the piston 286from shooting out of the handle bore 290.

This sudden snapping motion inverts the inverting member 151 to itsinverted configuration instantly so that a minimum amount of bloodescapes through the incision 82 in the blood vessel. Next, upward orproximal tension is applied to the device (preferably from the handle)to seal the edges of the inverting member to the inner wall of the bloodvessel.

FIG. 23 is a cross-sectional view of the hole puncher 178 of FIG. 21. Inone application of the present invention, the hole puncher 178 may beused to widen the initial slit incision 82 made in the aorta to create aproximal anastomosis site for a coronary bypass graft. The widened holeis preferably circular in shape, but may be elliptical.

The entire hole puncher 178 is preferably slidable along the extrusion160 between the inverting member 151 and the inverter control handle180. The proximal end of the hole puncher 178 preferably has acylindrically-shaped bore 154, which is internally threaded to receivethe threaded distal end 190 of the inverter control handle 180. The holepuncher 178 is screwed onto the distal end 190 of the inverter controlhandle 180 to prevent the hole puncher 178 from obstructing thepractitioner's way and interfering with the suturing and graftingprocess. This is shown in FIG. 23. Alternatively, instead of ascrew-type attachment, the attachment may be a clip or lockconfiguration. The connecting screw or lock may be designed in a varietyof ways.

The hole punch outer handle 170 is attached to the hole punch shaft 182.This attachment may be accomplished by a pin or other connecting piece.The hole punch inner handle 168 is slidably retained inside the outerhandle 170 and is attached to the hole punch enforcer 188. Hole punchspring 162 resides inside the hollow inner handle 168 and exertspressure to keep the inner handle 168 in an extended proximal position.Thus, when the hole puncher is dormant, the inner handle finger grips176 and the outer handle finger grips 174 are at their maximum distanceapart from one another.

When the medical practitioner pushes the inner handle finger grips 176toward the outer handle finger grips 174 (against the force of thespring 162), the hole punch enforcer 188 slides out further from theouter handle 170 (this motion may also be described as pulling the outerhandle finger grips 174 towards the inner handle finger grips 176).Also, the hole punch shaft 182 slides further into the hole punchaperture 172 because the hole punch shaft 182 is attached to the outerhandle 170. The hole punch enforcer 188 continues to slide until itmeets the radial edge 184 of the hole punch head 166. If thepractitioner continues to push, the hole punch head 166 slides insidethe hole punch aperture 172, leaving the hole punch enforcer 188 as themost distal piece of the hole puncher 178.

The use and operation of the hole puncher 178 will now be described withreference to FIGS. 25A-25E and 26. As described above, the medicalpractitioner makes an initial slit incision 82 in the blood vessel asshown in FIG. 25A. The practitioner inserts the inverting member 151 inits elongated narrow configuration as shown in FIG. 25. The practitionerexpands the inverting member 151 to its cup configuration, shown in FIG.25C, by pressing the releasor lever 218. Next, the practitioner appliesupward (proximally directed) tension to the device to seal the rim ofthe inverting member 151 to the inner wall 181 of the aorta asillustrated in FIGS. 25C and 25D.

The practitioner detaches the hole puncher 178 from the inverter controlhandle 180 (preferably by unscrewing the hole puncher 178) and slidingthe hole puncher 178 down the extrusion 160. Then, the practitionerinserts the head 166 of the hole puncher 178 into the incision 82. Thisis shown in FIG. 25D. Alternatively, the hole punch head 166 may beinserted simultaneously with the inverting member 151. The angled distalsurface of the hole punch head 166 allows it to penetrate the incision82 smoothly. Because of the slit-shape of the slit 82 and the naturalresiliency of the surrounding aorta wall tissue, the aorta walls 81close in around the distal portion of the hole punch shaft 182.

Using the outer handle finger grips 174 as a brace, the practitionerpushes the inner handle finger grips 176 toward the outer handle fingergrips 174. This compressing motion causes the hole punch enforcer 188 toextend toward the hole punch head 166 until the aorta wall is caughtbetween the hole punch enforcer 188 and the hole punch head 166. This isshown in FIG. 25E. When the practitioner continues to press, the holepunch enforcer 188 punches a circular hole around the incision 82 in theaorta wall 81. The interior surface 186 of the hole punch head 166 pullsthe discarded aorta wall tissue into the hole punch aperture 172 andinto the hollow interior of the inner handle 168. The practitioner thenwithdraws the hole puncher 178. When the practitioner releases the innerhandle finger grips 176 and outer handle finger grips 174, the holepunch spring 162 causes the hole puncher 178 to return to its startingposition. This allows the practitioner to remove the discarded aortawall tissue from the hole punch head 166.

Once the incision 82 is sufficiently widened by the hole puncher 178,the medical practitioner loosely sutures one end of a coronary arterybypass graft 226 to the aortic tissue surrounding the hole 82. This isshown in FIGS. 26A-28. The end 222 of the bypass graft 226 is preferablycut at an angle to facilitate blood flow and removal of the invertingmember 151. FIG. 26B shows an alternative method where a small slit ismade at the end 222 of the bypass graft to facilitate the removal of theinverting member 151.

With reference to FIGS. 27 and 28, a purse string stitch is preferablyused to suture the bypass graft 226 to the aortic tissue surrounding thehole 82. Alternatively, the practitioner may use a parachute suture oran interrupted suture. When the practitioner loosely sutures almost allthe way around the end 222 of the coronary artery bypass graft 226 withthe inverting member 151 still within the blood vessel, the end 222 ofthe bypass graft 226 forms the shape of a ‘cobra head’ 222.

When the suture 238 is in place, the medical practitioner pushes thetranslatable piston 17 of the inverter control handle 180 into the outerhandle 16. This causes the inverting member 151 to invert into itselongated, narrow configuration. The practitioner then removes theinverting member 151 from the aorta, and immediately pulls the ends ofthe suture 238 tight to bring the edges of the bypass graft 226 to theaorta (FIG. 28).

Although the embodiments described above use inverting members with acircular cross-section (cup-shaped), various other configurations arepossible. For example, the inverting member may have a conical,elliptical, saucer, or boat-shaped cross-sectional configuration.

Also, instead of expandable sleeving mesh, the inverting member maycomprise another compliant material with ribs or wires, or theexpandable sleeving may have ribs or wires in the mesh to give itstructure. Wires in the distal inverting portion 114 may be connected toa distal inverter head piece 152 and connected to other wires in aproximal inverting portion 156 with living or mechanical hinges.

Alternatively, the weave of the expandable sleeving mesh may besufficiently tight (e.g. less than one quarter inch) so that conceivablyno compliant material coating, such as silicone, is required on thedistal inverting portion 114. The weave of the braided mesh issufficiently tight to prevent the flow of blood through the mesh.

Third Embodiment

FIGS. 29-31 illustrate the distal portion of the device in accordancewith another embodiment of the present invention. The proximal portionof the device, including the handle, may be constructed according to oneof the above-described embodiments.

As depicted in FIGS. 29-31, the distal portion of the device comprises aflexible, hollow tube 242 with a plurality of slits 244 formed therein.The slits 244 extend longitudinally along the tube to define adeformable inverting member 151. The distal end of each slit 244 endsbefore it reaches the distal end 246 of the hollow tube 242.

As in the embodiments described above, the distal end 246 of the deviceis attached to a wire or shaft 232 (FIG. 31) which slides within thetube 242. Pulling the distal end 246 of the hollow tube 242 proximally(via the shaft or wire 232) relative to the proximal end 248 of thehollow tube 242 causes the walls 250 of the inverting member 151 to bendat a preformed creases as the walls move radially outward. The walls 250are preformed such that the inverting member 151 deforms in anumbrella-like manner to form a cup or saucer-shaped configuration (FIG.31). The walls 250 of the inverting member 151 may be formed from amaterial that has a considerably lower elasticity that the materialsused for the inverting members of the above-described embodiments.

The deformable inverting member 151 is preferably coated on the exteriorwith a flexible, impermeable material (not shown) such as siliconerubber to prevent blood from flowing through the incision 82 after thedevice has been deployed. The device may additionally or alternativelyinclude a stopper (not shown) inside the hollow tube 242 to preventblood from flowing up from the blood vessel through the hollow tube 242.

As with the embodiments described above, the device includes an actuatorassembly (not shown) for allowing the practitioner to remotely controlthe configuration of the inverting member 151 via the handle. The devicecan optionally be constructed with a hole puncher (not shown) of thetype described above.

The use and operation of this device will now be described with furtherreference to FIGS. 29-31. The operator inserts the inverting member 151into the incision 82 made in the blood vessel wall 81. The operator thenmanipulates the handle in same general manner as described above toapply a compressive force to the inverting member 151. This causes thewalls 250 of the inverting member 151 to expand outward away from thecenter of the hollow tube 242, and to then fold or pivot proximally toform a cup or saucer-shaped configuration. Because the slits are coveredby a flexible, impermeable material (not shown), the walls 250 ofinverting member 151 form a seal against the inner surface of the vesselwall 81 when the device is pulled distally.

The remaining steps of the procedure are preferably the same as in theembodiments described above.

An Alternative Handle

FIGS. 33, 34A-E, and 35A-C disclose an alternative handle 180′ that canbe used to deploy the inverting member 151. Although the handle 180′ maybe used in conjunction with a hole puncher, the hole puncher is notshown for the sake of clarity. Although the handle 180′ as well as itscounterparts described previously both deploy the inverting member, thehandle 180′ functions differently. In the first embodiment, as shown inFIGS. 13-16, for example, the inverting member is deployed by retractingthe translatable wire 11 (which is attached to the internal distal tipof the distal inverting member 14 via a retaining disk 13) while theextrusion 12 that surrounds the translatable wire 11 does not move andremains fixed to the proximal inverting member 15. Likewise, in thesecond embodiment, as shown for example in FIGS. 21-23, the translatablewire 111 is retracted to deploy the inverting member 151 while theextrusion 160 remains stationary.

In the alternative embodiment of FIGS. 33-35, however, the invertingmember 151 is deployed by moving the extrusion (tube) in the distaldirection relative to the handle 180′ while the translatable wireremains stationary relative to the handle 180′, the handle being held bythe practitioner. Although the movement of the extrusion relative tothat of the translatable wire (shaft) during deployment of the invertingmember is the same in this alternative embodiment as in the previouslydescribed embodiments, the embodiment of FIGS. 33-35 avoids a possiblecomplication that may arise during use of its counterparts.Specifically, when the translatable wire 111 is retracted to deploy theinverting member 151, the rim of the inverting member may abruptlycontact the vessel wall even though the handle is maintained stationary.This problem can arise if the inverting member is positioned too closeto the vessel wall prior to its deployment, and can potentially causethe inverting member to assume an improper configuration. Thealternative embodiment of FIGS. 33-35 eliminates this potential problem,as will be evident from the, discussion below.

FIG. 33 illustrates an overview of the handle 180′ through which theextrusion 160 and the translatable wire 111 pass. The extrusion 160 isdeployed by first depressing a button 304 (piston or cocking mechanism)which engages springs within the handle 180′, and then engaging atrigger 310. The handle 180′ includes a body 306 and threads 312 formating with a hole puncher (not shown). FIG. 34A shows the invertingmember 151 in its inverted position prior to cocking. The translatablewire 111 is secured by a set screw (not shown) such as a 4-40 screw thatpasses through a bore hole 316.

The handle 180′ is cocked (FIG. 34B) by depressing the button 304, whichcompresses a button spring 320 as well as a main spring 324, both ofwhich surround the translatable wire 111 and reside within a springcavity 328 in the handle 180′. The proximal end of the button spring 320fits within a groove 332 in the distal end of the button 304. The distalend of the button spring 320 resides within a groove 336 formed in aspring stop 340 that adjoins and is secured to the distal end of thehandle 180′. A lip 342 in the body 306 helps keep the spring stop 340 inplace. At its proximal end, the actuation spring 324 is located within acavity 344 of the button 304, in which cavity 344 adjoins and forms partof the spring cavity 328. At its distal end, the actuation spring 324contacts a catch head 348, which is seen most clearly in FIG. 35C (whichcorresponds to the cocked position of FIG. 34B). The catch head 348 issecured to the extrusion 160 so that they move together while slidingover the translatable wire 111. The catch head 348 is blocked at itsdistal end by a catch head stop 350 which is preferably integrallyformed with the spring stop 340. As the button 304 is depressed, thetranslatable wire 111, which is secured to the button 304, movesdistally so that the inverting member 151 moves to its undeployedposition, as seen in FIG. 34B. Upon fully depressing the button 304,locking arms 352 (shown in FIGS. 35A-C but not in FIGS. 33 and 34A-E),which are attached to the button 304, mate with the catch head 348, asillustrated in FIG. 35C. At this point, the handle 180′ is cocked.

As indicated in FIG. 34C, the handle 180′ will then move to its pre-fireposition by allowing the button spring 320 to push the button 304proximally (in the direction indicated by the arrow in FIG. 34C). As thebutton 304 is pushed back from the body 306 of the handle 180′, thelocking arms 352 pull the catch head 348 with it, and thus, theextrusion 160 to which the catch head 348 is attached is also retracted.The translatable wire 111, which is secured to the button 304 islikewise retracted, and thus, the entire inverting member 151 movesproximally relative to the body 306 of handle 180′ without changingshape.

As illustrated in FIG. 34D, the handle 180′ is triggered or activated bydepressing the trigger 310, which rotates about a trigger pivot 356. Thetrigger 310 includes a leaf spring 360 and two forks 364 which areslightly beveled (see FIG. 35B). As the trigger 310 is depressed,tension builds up in the leaf spring 360, which contacts a leaf springstop 368 and acts to return the trigger to its unflexed position afterthe trigger is released. Further, as the trigger 310 is depressed, theforks 364 enter the spring cavity 328 to engage the locking arms 352, asseen most clearly in FIGS. 35B and 35C. As indicated in FIG. 35C, thisforces the locking arms 352 apart, and releases the catch head 348 fromthe locking arms 352. The tension in the activation spring 324 urges thecatch head 348 and the extrusion 160 to which it is attached to movedistally, while the translatable wire 111 remains stationary. Since theextrusion 160 and the translatable wire 111 are secured to the proximaland distal ends of the inverting member 151, respectively, the effect ofthe extrusion moving distally while the translatable wire remainsstationary is to deploy the inverting member 151 without moving thedistal tip of the inverting member in the proximal direction. This isseen by comparing FIGS. 34D and 34E, in which the position of vesselwall 81 in these figures does not change with respect to the handle180′, and FIG. 34E shows the inverting member 151 deployed. Thus, anyrisk of contact between the inverting member 151 and the vessel wall 81during the inversion process is reduced.

The handle 180′ further includes a shock absorbing spring 372 that islocated within and (when relaxed) extends out of the catch head stop350. The purpose of this spring 372 is to prevent the inverting member151 from being deployed too rapidly. Specifically, as the catch head 348is being thrust in the distal direction, but before the inverting member151 is completely deployed, the catch head runs into the shock absorbingspring 372, which is compressed and thereby acts to decelerate the catchhead and the extrusion 160 to which the catch head is attached. Theeffect is that the inverting member 151 is fully deployed, but lesssuddenly than if the shock absorbing spring 372 were absent. Further,spring 372 protects the catch head stop 350 by reducing the force ofimpact of the catch head 348 onto the catch head stop 350.

It will be appreciated from the foregoing that other types ofdeformable, flexible members can be used to form the cup within theartery, including flexible members that do not invert. For example, aflexible member which opens and closes like an umbrella (withoutinverting) could be used.

While certain preferred embodiments and particular applications of thisinvention have been shown and described, it will be apparent to thoseskilled in the art that various modifications can be made to thesedesigns without departing from the scope of the invention. It is,therefore, to be understood that, within the scope of the appendedclaims, this invention may be practiced otherwise than as specificallydescribed above.

What is claimed is:
 1. A device for creating a seal around an incisionin a blood vessel which allows blood to flow through the blood vessel,comprising: a tube; a shaft slidably mounted within said tube; aretaining member which prevents relative movement between said shaft andsaid tube, said retaining member being releasable to allow said relativemovement; a deformable sealing member adjoining distal ends of saidshaft and said tube, said sealing member being reversibly adjustable,between: an elongated, narrow configuration for insertion of saidsealing member through the incision; and a sealing configuration inwhich (i) a first portion of said sealing member seals against an innerwall of the blood vessel, and (ii) a second portion of said sealingmember, interior to said first portion, is spaced from the inner wall ofthe blood vessel to form a cavity which provides a region of hemostasiswithin the blood vessel; wherein the configuration of said sealingmember is changed by movement of said shaft relative to said tube. 2.The device of claim 1, wherein said sealing member comprises a preformedtubular member.
 3. The device of claim 1, further comprising a handlethat is operatively coupled to said tube and said shaft to allow apractitioner to remotely adjust the configuration of said sealingmember.
 4. The device of claim 2, said handle comprising a spring whichwhen released urges said tube away from and distal to said handle andcauses said sealing member to invert.
 5. The device of claim 4, whereinsaid sealing member remains separated from the inner wall of the vesselwhile said sealing member is inverted.
 6. The device of claim 4, whereinsaid sealing member is inverted by moving said tube.
 7. The device ofclaim 4, wherein said tube is moved distally relative to said handle andsaid shaft to deploy said sealing member.
 8. An apparatus, comprising:first and second shafts; and a sealing member comprising proximal anddistal inverting members, said inverting members connected to said firstand second shafts, respectively, such that a first relative movement ofsaid shafts positions said proximal inverting member inside said distalinverting member, and a second relative movement of said shafts oppositeto said first relative movement inverts said proximal inverting memberto position said proximal inverting member outside said distal invertingmember.
 9. The apparatus of claim 8, wherein said distal invertingmember has a substantially conical shape when said proximal invertingmember is inside said distal inverting member, such that said sealingmember forms a cavity.
 10. The apparatus of claim 8, wherein saidsealing member has a first position juxtaposed with one of said shaftsand a second, expanded position sized to seal around an opening intissue, and wherein said relative movement has a range of motion, oneend of said range providing said first, juxtaposed position and anotherend of said range of motion providing said second, expanded position.11. The apparatus of claim 8, wherein one of said shafts comprises atube and the other of said shafts comprises a rod within said tube. 12.A method of occluding an opening into a blood vessel, comprising:providing a pair of inverting members that are operably connected to ahandle, each inverting member having an apex portion and a base portion,said base portions being attached to each other; positioning saidmembers so that said apex portions are spaced apart such that saidmembers provide a narrow elongated configuration; inserting said membersinto said opening in said elongated configuration; positioning saidmembers so that said apex portions of said members are adjacent to eachother such that at least one of said members forms a cavity between itsbase portion and its apex portion; positioning said inverting members sothat said cavity provides a region of hemostasis around said openingwithin said blood vessel; and withdrawing the handle away from the bloodvessel such that the inverting members are removed from the bloodvessel.
 13. A method of creating a region of hemostatis in a bloodvessel while allowing blood to flow in the vessel past the region ofhemostatis, said method comprising: providing a sealing membercomprising a sleeve having a pair of ends and a portion intermediate theends which (i) expands outwardly in response to movement of the ends ofthe sleeve towards each other and (ii) contracts inwardly in response tomovement of the ends of the sleeve away from each other; inserting thesealing member into the blood vessel with the ends of the sleevesufficiently separated so that said sleeve is in an elongated,substantially unexpanded condition; positioning the sealing member at adesired location in the blood vessel; moving the ends of the sleevetowards each other to expand the intermediate portion such that theintermediate portion seals against an inner wall of the blood vessel forforming the region of hemostasis; and removing the sealing member fromthe blood vessel.
 14. A method of forming an anastomosis site along thewall of a blood vessel comprising: advancing a deformable sealing memberthrough an incision in a wall of the blood vessel, the sealing membercoupled to first and second members which are slidably mounted to oneanother; moving the first and second members relative to one anotherfrom outside the blood vessel to cause the sealing member to deform to acup having a rim; and moving the sealing member proximally within theblood vessel to cause the rim to form a seal against an inner surface ofthe blood vessel wall, to thereby form a region of hemostasis within theblood vessel.
 15. The method of claim 14, wherein the sealing membercomprises a flexible member which interconnects the first and secondmembers, and wherein the step of deforming the sealing member comprisesactuating a handle which causes one of the members to be advanceddistally while the other member is maintained stationary.
 16. The methodof claim 14, further comprising: slidably advancing a hole punch devicedistally along at least one of the first and second members to theincision with the sealing member forming a seal; and actuating the holepunch device to form an anastomosis opening in the wall of the bloodvessel within a boundary of the seal.
 17. A method of forming ananastomosis site, the method comprising: accessing a blood vessel of apatient; making an incision in a wall of the blood vessel and insertinga sealing member into the blood vessel with the sealing membermaintained in an elongated, narrow configuration; deforming the sealingmember to form a cup; applying tension to the cup through the incisionto seal a rim of the cup to an interior surface of the blood vessel wallwithout interrupting the flow of blood through the blood vessel; andadvancing a suture through the wall of the blood vessel adjacent the rimof the cup while the sealing member is within the blood vessel.
 18. Amethod of forming an anastomosis site, the method comprising: accessinga blood vessel of a patient; making an incision in a wall of the bloodvessel and inserting a sealing member into the blood vessel with thesealing member maintained in an elongated, narrow configuration, whereinthe sealing member comprises a flexible member which interconnects adistal end of a tube to a distal end of a shaft, the shaft slidablymounted within the tube; deforming the sealing member to form a cup,wherein the step of deforming the sealing member comprises actuating ahandle which causes the tube to be advanced distally over the shaftwithout moving the shaft; and applying tension to the cup through theincision to seal a rim of the cup to an interior surface of the bloodvessel wall without interrupting the flow of blood through the bloodvessel.
 19. A method of forming an anastomosis site, the methodcomprising: accessing a blood vessel of a patient; making an incision ina wall of the blood vessel and inserting a sealing member into the bloodvessel with the sealing member maintained in an elongated, narrowconfiguration; deforming the sealing member to form a cup, wherein thesealing member comprises a flexible member which interconnects a distalend of a tube to a distal end of a shaft, the shaft slidably mountedwithin the tube, and wherein the step of deforming the sealing membercomprises actuating a handle which causes the tube to be advanceddistally over the shaft without moving the shaft; applying tension tothe cup through the incision to seal a rim of the cup to an interiorsurface of the blood vessel wall without interrupting the flow of bloodthrough the blood vessel; slidably advancing a hole punch devicedistally along the tube to the incision with the sealing member forminga seal; and actuating the hole punch device to form an anastomosisopening in the wall of the blood vessel.
 20. A method of forming ananastomosis site, the method comprising: accessing a blood vessel of apatient; making an incision in a wall of the blood vessel and insertinga sealing member into the blood vessel with the sealing membermaintained in an elongated, narrow configuration; deforming the sealingmember to form a cup; applying tension to the cup through the incisionto seal a rim of the cup to an interior surface of the blood vessel wallwithout interrupting the flow of blood through the blood vessel; andattaching a tubular graft to said blood vessel, said attachingcomprising (a) positioning edges of an end of the tubular graft so thatthe edges surround the incision, and (b) fastening the edges to theblood vessel such that the graft is sealed against the vessel.